22,000 People Died As Bayer Reaped Profits, Withheld Key Study From FDA

By consumeristcareyFebruary 17, 2008

The FDA yanked the heart surgery drug Trasylol off the market last November, but a medical researcher now claims that 22,000 lives could have been saved if Bayer AG hadn’t withheld the results of an earlier internal study proving the drug’s danger. An FDA committee held hearings in September 2006 to determine Trasylol’s safety, but three of the committee members had a financial interest in Bayer, and the drug maker had underwritten the committee chairman’s research.

[Drug researcher Dr. Dennis Mangano] believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug’s use with kidney failure requiring dialysis and increased death of those patients. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” says Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month,” he tells Pelley.

In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano’s results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. “The [Bayer] representatives at the meeting…should have disclosed fully to the FDA that a study was done…even put the meeting in abeyance until the data were found or discussed,” Mangano tells Pelley. “Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin,” he says.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,” he tells Pelley.

Dr. Hiatt, who wrote three papers underwritten by Bayer, may be sorry now, but he had no problem skewering Dr. Mangano’s research at the time. The full story complete with scary graphics and ominous music will air tonight on 60 minutes.

Couldn’t the doctor be a savior and just release his results outside the company? But no, for some reason he felt compelled that even after his time spent on research, that it was ‘right’ to not betray the company to save people.

All involved with the cover up for the greed of profits should be lined up and shot in the face. If I worshipped money like that, I would fear my death, because I am pretty sure the Spirit in the Sky said “Thou shall have no other Gods before me.” Vengence shall be his…

There is too much money in this industry. Next they will sell it as a huckster on a TV ad. Show worn out old fogies that take this drug and turn into young dancing fools wondering about the next disco dance… then a warning to check the ad about the little side effect of death in some unavailable magazine.

Corporate shareholders are happy with the profits. Heck they are saving lives and bank accounts. The dead are not complaining and managed health care does not have to pay to keep them alive anymore.

I just hope whomever ends up in the White House next year pushes to deal with fixing the FDA. The current batch of clowns were busy telling us all that buying drugs from Canada was dangerous and having them seized at the border while they were doing this.

Don’t we have some sort of federal laws against this kind of corruption? Or is it agency by agency?

@bohemian: Let’s not try to put all this on the FDA. Bayer withheld results of a study whose data confirmed Managano’s findings. Had that information been disclosed, there would not have been that long delay in removing the drug from the market.

If you are involved in healthcare, you must put patient welfare above profit. How can these people at Bayer sleep at night?

So sad, but does not surprise me–this is the same company that paid out millions to settle a class action law suit brought by those who contracted AIDS from Bayer’s blood clotting factor drug (administered to hemophiliacs).

Wow! That means that Bayer is now America’s most prolific serial killer! But wait, that is OK because in here in he US if you are a major corporation or you have an M.D. you can literally get away with murder.

Every employee who had his hand in postponing a recall should be charged with negligent homicide. Too often corporations get away scott free because the biggest threat they have are fines, which just get go against the bottom line- and eventually absorbed in the stock price. BIG DEAL.

I think holding the human beings from the top down accountable criminally would be a good start in ensuring end user safety.

@ClayS: That’s fair, as long as you leave SOME significant responsibility with the FDA, because under W it’s become common to have things happen like committee chairmen who have a financial interest in the companies their committees oversee. This needs to stop, whoever wins this next time around.

@flamincheney: I agree. I’m all for letting business make plenty of profit, but when human lives are knowingly being lost, there needs to be some serious accountability. Nuremberg would be an appropiate venue for the criminal trials.

@GearheadGeek: don’t be foolish. the fda has been corrupt since its inception. i’m not one to defend the current administration, but making a statement like “whoever wins this next time around”? bah! whoever wins, we all lose.

@mac-phisto: So you don’t think “This needs to stop” as I said? It’s possible that the next president will be as corrupt and ineffectual (though not likely as disinterested and simplistic) but it’s a certainty that W and his goons aren’t going to fix anything, so the only valid excuse for any sort of hope is “whoever wins this next time around.”

@mac-phisto: While I’ll grant you that the FDA has had a basic conflict of interest since its inception, relying on self-reported drug industry trials for approval, etc., it’s been made much worse by W by being politicized in addition to further corrupted by ties to industry.

@GearheadGeek: the ties form the very foundation of our government & bureaucracy though. they cannot be unbound. that is what government is. have you not heard of the “iron triangle”?

power is so centralized within our current system that it matters not who is elected – industry has friends on both sides of the aisle.

one could argue that change is good, but does it even matter? to me, it’s like a box of wheaties. doesn’t matter if marylou retton or karem abdul-jabar is on the outside, as long as they get you to eat what’s inside & like it!

personally, i feel that the less that gets done in washington, the better off i am. i’ll play the odds at the state & local level, thank you very much.

@flamincheney: Your right. At some point a human with decision making ability decided to hide this study in order to make more money. Someone knowingly to kill people to make a buck and they need to go to prison for a long time. It might have been a handful of decision makers at Bayer agreed to this or one person, but whomever did this needs to be held accountable in a criminal court. Civil fines are a joke to these people.

@mac-phisto: I see, the Ron Paul theory. I think companies would likely buy their influence locally and more cheaply at that level. I don’t see any reasonable way for a state government to regulate medicines, they’d still be getting all of the “research” from the pharmaceutical companies they supposedly regulate.

There’s the possibility that it would make government affordable for some people… I can see that happening in New Hampshire with the “town meeting” concept taking care of lots of decisions and possibly actually reflecting the will of the people. CA probably wouldn’t be any worse off than it is now. Louisiana would be a cruel joke.

The FDA as a concept is one of the things that’s ideally federal. Its implementation is flawed, like so many other things done by our 1.25-party system, but I think it’s less bad than the chaos we’d have with 50 state agencies presenting differing standards and requirements to companies and offering differing protections to their respective citizens.

the problem with the fda is that it’s federal. by centralizing the bureau that decides what is good & what is bad for all citizenry, we have eliminated the ability to inject alternative views altogether. a drug comes along, the fda rules good or bad & we must accept the consequences either way – what glorious power we have given them!

by Benjamin Franklin
Speech given during the Constitutional Convention
1787

…Sir, there are two passions which have a powerful influence in the affairs of men. These are ambition and avarice; the love of power and the love of money…Place before the eyes of such men a post of honor, that shall, at the same time, be a place of profit, and they will move heaven and earth to obtain it…The struggles for them are the true source of all those factions which are perpetually dividing the nation, distracting its councils, hurrying it sometimes into fruitless and mischievous wars, and often compelling a submission to dishonorable terms of peace.

And of what kind are the men that will strive for this profitable pre-eminence, through all the bustle of cabal, the heat of contention, the infinite mutual abuse of parties, tearing to pieces the best of characters? It will not be the wise and moderate, the lovers of peace and good order, the men fittest for the trust. It will be the bold and the violent, the men of strong passions and indefatigable activity in their selfish pursuits. These will thrust themselves into your government, and be your rulers…

@Applekid: “A division of Bayer sold millions of dollars worth of a medicine that carried a high risk of spreading HIV to hemophiliac customers in Latin America and Asia, while selling a new, safer product in the European and US markets, reported the New York Times.”[www.thebody.com]

60 Minutes just carried a piece on this story, and it made me nauseated. There is no level too low for money to provide the motivation to travel.

The parties involved should be held liable for each and every one of the 22,000 deaths that were caused since Bayer concluded their research, if not more since their was data readily available showing the risk of this drug.

The worst part was when they showed that low risk drugs were available for $50, as where Trasylol cost $1000. Ethics, integrity, and respect for humanity is withering away.

Remember the case where many dogs, cats, and even people had organ damage mainly kidney damage from the food that was made in China and then sold to animals and people. Well, the trial took only one week and the man in charge of the Chinese FDA, was found guilty. He was bribed by the companies who wanted to save money on safety costs. As a result and I don’t know if people in America, and in other Countries died, but many animals did die. So he was promptly executed. And as we all know that if found guilty under Chinese rules, as a citizen you do have a right to appeal but if the appeal court cites with the first court as in appeal denied, then you are executed within days if not hours. Chinese are ruthless bastards, but get the job done on corruption after all this press. The bad toys, and food. Now, if this was the case in America, or in another democratic country, I think he could have gotten about 5-10 years if people did die. Sadly, no one would even care about the animals other than paying the owners of the animals some large settlement that would be divided between them. And I agree with you on the part where these bastards should be shot execution style. Bayer or another company don’t remember even sold to other countries a lot of tainted HIV tablets for headache or something like that. They knew they were tainted with HIV virus and could not sell them to US. Market bit had no problems with selling it to Other countries where now many people are sick and dying from AIDS. The virus was buried in the tablets and because viral DNA resides in a protein shell and just need a host to be active many did get infected while the company got profits. Never take any medication unless you absolutely have to. Corporate greed is everywhere but something has to be done about those bastards. I can’t even name them as people because they are not people. Just a bad seed that has to be cut out like cancer from this society.

The drug companies own the FDA. Bayer’s main goal in this case appears to be to hold off a ban of the drug as long as possible to get as much profit as they can to pay off the coming lawsuits and still be sitting pretty after the dust settles. The cost in lives and court cases is just the cost of doing business. Nothing more, nothing less. THEY DON’T CARE ABOUT PEOPLE.

As a different perspective, it is a shame that 22,000 people died, but according to his study, 431,000 people took the drug. So 95% of the people who took the drug lived. Now if the drug had been taken off the market, how many of these 431,000 would have died? Is it less or more than 22,000?

Obviously, there is no way of knowing the answer. FDA regulation recalling or preventing drugs means it isn’t available to some who may willingly take it. So that is something else to take into account. There are cancer drugs that are considered risky and can’t get FDA approval that some patients are willing to take, to improve their life.

In case it isn’t clear,I am not saying it is acceptable for Bayer to hide the results of their study. I am saying that just because a drug has issues, or risks, doesn’t mean some people don’t benefit from it.

@bnb614: In the 60 Minutes piece, the guy who did the independent study and testified before the FDA said that there are 2 other drugs with similar efficacy, none of these negative side effects and they cost about $50/treatment, compared to $1,000/treatment for Trasylol. So, while it’s true that not everyone died, it’s likely that a huge portion of teh 22k people who DID die could have been treated with one of the less-damaging drugs at a much lower cost to their insurance companies.

The best way to rip the Bayer execs and FDA tools a new one would be to get the insurance industry to figure out how much more they spent on Trasylol for 431,000 people than they would have for alternative treatment and let them release the hounds.

The 60 Minutes expose showed two products that existed prior to the use of Trasylol. The two other cost $50 compared to the $1000 price tag of the designer drug. From what the medical experts were saying I understood it that Trasylol was an ideal option only for a VERY few cases, but thanks to widespread and heavy-handed pushing became drug of choice.

So essentially if the drug were completely pulled when Bayer was supposedly became aware it would have saved many, many lives.

My wife works in heart surgery, and used this drug daily until it’s recall. She still uses it in very bad cases (extra permission of some sort is now needed) because it’s the best drug available. Believe me, she would know.

It basically keeps people from bleeding to death, and has for about 30 years. Funny that they’re seeing increased mortality in a sample group, but not in a population that’s been using it for a few decades, isn’t it?

This study is flawed, plain and simple, so everyone out their blowing your “corporate greed” whistle should wait a second and learn a little about heart surgery before assuming the worst. Trasylol, more commonly referred to as Aprotinin, was used in many (read: nearly all) heart surgery cases that require going on a bypass machine. Patient records do NOT show people dying from this drug in the numbers that this study is showing them, and yes, I am using anecdotal evidence, but it’s more than anyone else on this comment list has, so it’s as fair game as anything else. This drug has been in use for a long time now – check wiki and you’ll see that it’s at least since the 70’s. The heart surgeons who have been in the game for decades are still pissed that they can’t use this – because it’s the best available. They aren’t all assholes trying to make a buck, either – some really do it to save people’s lives, and not using aprotinin makes that harder. I’m not going into details because I can’t (my wife could, but she’s busy in a heart surgery case right now :P ), but suffice it to say that if you are in very bad shape, you should still use aprotinin, because you’re kidney function (e.g.) is the least of your worries.

That’s what the study isn’t saying – aprotinin is used on people who need it badly, who have a high chance of essentially bleeding to death (for a variety of reasons, generally patient-related, such as previous medications and genetic conditions) during surgery, and these patients are surviving cases that they wouldn’t otherwise because there is NO next best drug. I’m not saying everyone should get this drug, of course. We all watch House, right? It’s not real, sure, but in some circumstances you really do choose between one treatment method with an increased mortality rate and a much lower survival rate during surgery. There are legitimate uses for this drug, and the study numbers are coming back with such high mortality rates because the people who are given the drug *had higher mortality rates*. They were sicker, otherwise they didn’t need aprotinin. Now I’m sure the study is not so poorly done as to not take that into account, but if you worked in a hospital every day or worked with patient records, you would see that this study simply doesn’t jive with real-world numbers.

Read the actual study, and you’ll see that what is raised is “all cause mortality.” It’s a give and take with medications and surgeries, always, and I hope Aprotinin isn’t causing undue harm to anyone. I also think Bayer should have released the results ASAP, and in fact all medical/fda studies should be public a lot sooner than they are, if they ever are.

However, the news (as usual) is not reporting the facts, but instead reporting an alarmist version of them. No where did they mention trasylol’s history. If anyone on this list is asked by a heart surgeon if they would allow aprotinin to be given to them during their surgery, chances are the answer ought to be “yes.”

@luminus: Thank you. This knee-jerk anti-business stuff on this site is getting ridiculous.

Much more likely is that this DR. Mangano has an ego problem. His precious study should trump 40 years of good medicine. 40 years of saving lives. How many of the readers here have parents or grandparents who have had life-saving heart surgery? Well guess what, you owe part of their survival to this drug.

@swalve: Uhhh.. yeah, because we all know that corporate execs always have the best interests of society when they make their decisions. Maybe the reason so many of us have a knee-jerk reaction to business is because by and large, big business is full of scumbags with little on their minds but padding their own wallets…

@luminus: So Bayer’s OWN report supported the whistle-blowing doctors report, they knew it and withheld it. And since there are two other drugs with similar efficacy rates and no risk of higher mortality, why use it except in the most extreme of circumstances?

That part of the 60 minutes report (about there being 2 identical, significantly cheaper alternatives) is simply not true. I can’t believe they had the gaul to make a claim like that. Ask ANY heart surgeon, and they will tell you that is a load of BS, and that they would still use Aprotinin if it were available 999 out of 1000.

I wonder if 60 minutes will do a follow up report on the number of people who will die from surgical complications because Aprotinin is not available. Somehow I doubt this.

The dangers of Aprotinin were already well-known in the medical community. This is another detail glaringly missing from the 60 Minutes piece. I doubt any cardiac surgeon would bat an eyelash to either the NEJM study or Bayer’s follow-up.

Is Bayer’s nose clean on this? Of course not. They should have published the results of the study immediately. It was highly irresponsible on their part.
BUT, as a physician, I found the reporting on 60 Minutes to be very, very distorted and misrepresentative of the facts (not unlike pretty much any medical story in the MSM).